Nonresident, Out of State
New York State Law requires that the State Board of Pharmacy register all pharmacies, manufacturers, repackers and wholesalers that are physically located out of New York State but ship, mail, deliver, invoice or provide samples of prescription drugs or prescription devices into New York State. Our nonresident registration law (6808-b) went into effect on March 19, 2003. Applicable regulations can be found at Regulations of the Commissioner (63.8)
For information on the number of pharmacies, manufacturers, repackers, and wholesalers that ship, mail, deliver, invoice or provide samples into New York State see License Statistics.
Registration ensures public oversight of these businesses, supports the issuance of related permits, assures delivery of prescription drugs to properly authorized facilities, and provides a means of assuring the purity, potency and safety of medications distributed in New York State.
Nonresident business entities that do business in New York State must have a registered agent for service of process in New York State. A resident agent is a contact person (e.g. New York State lawyer) or agent to receive legal papers when a corporation is served for a legal reason. This resident agent may work for a fee and forward legal papers to the corporation that is being served.
If you do not have a registered agent for service of legal reasons, we refer you to Sections 304 and 305 of the New York State Business Corporation Law which require that the Secretary of State of New York be designated as agent for service of process for every foreign or domestic corporation doing business in New York.
You may contact the New York State Department of State at 518-473-2492. Additional information, instructions and application forms are available at the Department of State's Web site at http://www.dos.state.ny.us/corp/corpwww.html .
Do You Need to Register?
- Manufacturers, repackers, or wholesalers must register to do business in New York State if they ship, mail, deliver, provide sample or invoice prescription drugs or devices into New York State. This would be drugs and devices that indicate "Rx Only" or "Federal Law prohibits dispensing without a prescription."
- The sale of catheters or other devices that have a caution
label "Federal Law prohibits dispensing without an order" is
an indication of a non-prescription device.
Example: A catheter is not a prescription device.
A contraceptive diaphragm is a prescription device.
- New York State Department of Health Regulations require needles and syringes to be dispensed as prescription devices in New York State. You may reference Department of Health Regulation Part 80 for pertinent information.
- A wholesaler may not sell or distribute needles and syringes to an individual person in New York State. This is dispensing and requires an individual prescription.
As defined in the Regulations governing New York State NonResident Pharmacy and Wholesaler registrations, establishments that meet the criteria of an "isolated transaction" are NOT REQUIRED TO REGISTER.
Isolated transaction means for pharmacies, 600 or fewer prescriptions per calendar year for drugs and/or other devices delivered into New York State, and for manufacturers and wholesalers, sales that total less than $10,000 in value, at wholesale per calendar year, for drugs and/or devices delivered into New York State, except that upon application by a nonresident establishment, the department may deem a transaction to be an isolated transaction, when such transaction is necessary to protect the public health by addressing a temporary emergency shortage of a prescription drug and/or device in New York State.